Flexible, sterile container and method of making and using same

• US 5,462,526 A
• Filed: 09/15/1993
• Issued: 10/31/1995
• Est. Priority Date: 09/15/1993
• Status: Expired due to Term

• Current Assignee: B Braun Medical Incorporated (B. Braun Holding GmbH & Co. KG)
• Original Assignee: McGaw, Inc. (B. Braun Holding GmbH & Co. KG)
• Inventors: Smith, Steven L., Barney, Ward W.
• Primary Examiner(s): Green, Randall L.
• Assistant Examiner(s): ZUTTARELLI, ANTHONY
• Application Number:
  US08/121,614
• Time in Patent Office: 776 Days
• Field of Search: 604/56, 604/82-92, 604/403-404, 604/408-410, 604/416, 128/DIG. 24
• US Class Current: 604/85
• CPC Class Codes: A61J 1/10 Bag-type containers
• CPC Class Codes: A61J 1/2024 having peelable seals
• CPC Class Codes: A61J 1/2093 Containers having several compartments for products to be mixed
• CPC Class Codes: A61M 2207/00 Methods of manufacture, assembly or production
• CPC Class Codes: B32B 2307/31 Heat sealable
• CPC Class Codes: B32B 2439/80 Medical packaging
• CPC Class Codes: B32B 27/08 of synthetic resin
• CPC Class Codes: B65D 81/3272 formed by arranging one flexible container within another

Abstract

A flexible, sterile container is provided for sterile storing and mixing of medicaments and liquids which includes a shell with at least one compartment. At least one sterile liquid-containing pouch is in one of the compartments, and a medicament is in the compartment with the pouch or is in a different compartment. The liquid and medicament are mixed together by squeezing the shell and pouch to rupture the pouch to release the liquid for mixing with the medicament just prior to dispensing the mixture.

Claims

1. A flexible, sterile container for storing and mixing medicaments and diluent liquids in a sterile environment, and dispensing mixtures thereof, comprising:

a flexible shell having a top, bottom and sides with a sterile interior;

at least one sterile compartment within said shell;

at least one medicament disposed within said at least one sterile compartment;

at least one sterile, self-contained, flexible pouch containing a diluent liquid suspended within said at least one sterile compartment, wherein the sterile pouch is permanently connected along an upper edge to a top portion of the flexible containers, said flexible pouch being rupturable by application of pressure to the shell and pouch sufficient to release the liquid into the sterile compartment for subsequent mixing with said medicament without rupturing the shell; and

dispensing means for dispensing a mixture of liquid and medicament from said container.

2. A flexible, sterile container according to claim 1 further comprising a plurality of self-contained flexible pouches containing liquid disposed within said at least one sterile compartment, each of said pouches being rupturable by application of pressure sufficient to rupture said pouches and release liquid contained therein into the sterile compartment for mixing with medicament, without rupturing the shell.

3. A flexible, sterile container according to claim 1, wherein the medicament is in dry powder form.

4. A flexible, sterile container according to claim 1, wherein the medicament is in liquid form.

5. A flexible, sterile container according to claim 1, wherein the diluent liquid is a dextrose solution.

6. A flexible, sterile container according to claim 1, wherein the diluent liquid is a saline solution.

7. A flexible, sterile container according to claim 1, wherein the pouch comprises a peelable seal along one of its edges and is rupturable along said peelable seal by application of pressure to the shell and pouch sufficient to release the liquid through the ruptured seal.

8. A flexible, sterile container according to claim 1, wherein the diluent pouch is formed from two facing polymeric sheets which are heat-sealed around their edges, and wherein a seal along the top edge of the pouch defines a flange, wherein said flange is permanently connected to a top portion of the shell.

9. A flexible, sterile container according to claim 8, wherein the container shell comprises front and rear polymer sheets which are bonded together around their perimeter, the pouch being connected to the top portion of the shell by means of the pouch seal flange being trapped within the perimeter bond between the sheets along a top portion of the container.

10. A flexible, sterile container according to claim 1, wherein the shell comprises a plurality of sterile compartments, further comprising:

at least one flexible, sterile diluent-containing pouch disposed within a first compartment and a medicament disposed in a second adjacent compartment, said flexible pouch being rupturable by application of pressure to the shell and pouch sufficient to rupture the pouch without rupturing the shell to release the diluent liquid contained in the pouch into the first sterile compartment;

a removable seal between adjacent compartments so that, upon removal of such seal, adjacent compartments are in fluid communication; and

dispensing means to dispense a mixture of medicament and liquid.

11. A flexible, sterile container according to claim 10 comprising two sterile compartments containing liquid and medicament, respectively.

12. A flexible, sterile container according to claim 10 comprising three sterile compartments;

a first compartment containing at least one flexible diluent-containing pouch, a second compartment adjacent said first compartment containing a powdered medicament, and an initially empty third compartment adapted to receive and contain a mixture of liquid diluent and medicament from the first and second compartments;

removable seals between the first and second compartments and between the second and third compartments; and

dispensing means for dispensing a mixture of medicament and liquid diluent from the third compartment.

13. A flexible, sterile container according to claim 10, wherein the medicament is selected from a dry powder medicament and a liquid medicament.

14. A flexible, sterile container according to claim 10, wherein the sterile pouch is permanently connected along its upper edge to a top portion of the first compartment.

15. A flexible, sterile container according to claim 10, wherein the pouch comprises a peelable seal along one of its edges and is rupturable along said peelable seal by application of pressure to the shell and pouch sufficient to release the liquid through the ruptured seal.

16. A flexible, sterile container according to claim 10, wherein the diluent pouch is formed from two facing polymeric sheets which are heat sealed around their edges, and wherein a seal along the top edge of the pouch defines a flange, wherein said flange is permanently connected to that portion of the shell that defines the top portion of the first compartment.

17. A flexible sterile container according to claim 10, wherein the container shell comprises front and rear polymer sheets which are bonded together around their perimeters, the pouch being connected to the top portion of the shell by means of a sealed flange along the pouch top edge being trapped within the perimeter bond between the sheets along a top portion of said container.

18. A flexible, sterile container according to claim 17, wherein the flange of the pouch heat seal incorporates a plurality of holes therethrough, and material from the container perimeter bond has flowed through and bonded together through said holes.

19. A flexible, sterile container for storing and mixing medicaments and diluent liquids in a sterile environment, and dispensing mixtures thereof, comprising:

a flexible shell having top, bottom and sides defining three sterile compartments and formed from front and back facing polymeric sheets wherein each of said sheets has a perimeter therearound, a first of said compartments at the top of the shell containing at least one flexible, sterile, diluent-filled pouch, a second of said compartments adjacent the first compartment containing a sterile powdered medicament, and an initially empty third compartment at the bottom of the shell adapted to receive and contain a mixture of the liquid diluent and the medicament from the first and second compartments;

a heat seal provided around the perimeter of the flexible sheets, bonding said flexible sheets together, and peelable seals between the first and second compartments and between the second and third compartments, said pouch being heat sealed along one edge and having a peelable seal along another edge, wherein the heat seal forms a flange which is connected to an upper edge of the first compartment; and

dispensing means for dispensing a mixture of medicament and liquid diluent from the third compartment.

20. A flexible, sterile container according to claim 19, wherein the medicament is selected from a dry powder medicament and a liquid medicament.

21. A flexible, sterile container according to claim 19, wherein the diluent liquid is a selected from a dextrose solution and a saline solution.

22. A flexible, sterile container according to claim 19, wherein the flange of the pouch heat seal incorporates a plurality of holes therethrough, and material from the container perimeter heat seal at the upper edge of the first compartment has flowed through and bonded together through said holes.

23. A flexible, sterile container for storing and mixing medicaments and diluent liquids in a sterile environment, and dispensing mixtures thereof, comprising:

a flexible shell having a top, bottom and sides with a sterile interior;

a plurality of sterile compartments within said shell;

at least one flexible, sterile diluent-containing pouch suspended within a first sterile compartment and a medicament disposed in a second adjacent sterile compartment, said flexible pouch being rupturable by application of pressure to the shell and pouch sufficient to rupture the pouch without rupturing the shell to release the diluent liquid contained in the pouch into the first sterile compartment;

a removable seal disposed between adjacent compartments so that, upon removal of such seal, adjacent compartments are in fluid communication; and

dispensing means to dispense a mixture of medicament and liquid from said container.